PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.

Your Role

We are seeking a highly experienced ETO Sterilization Engineer with a strong background in validation and protocol development within the pharmaceutical or medical device industry. This role is critical in supporting the qualification and validation of ethylene oxide sterilization processes to ensure compliance with industry standards and regulatory expectations. You will lead the planning, execution, and documentation of EtO sterilization validations and contribute to lifecycle management and regulatory readiness.

Key Responsibilities: Develop and execute IQ/OQ/PQ protocols for EtO sterilization cycles in accordance with ISO 11135 and internal quality standards.

Author and manage validation lifecycle documents including protocols, reports, risk assessments, and SOPs.

Collaborate with cross-functional teams to ensure timely and compliant validation efforts.

Evaluate and analyze process data, including EtO concentration, temperature, humidity, and exposure time to confirm sterilization effectiveness.

Identify and mitigate risks during EtO validation activities to support robust and reproducible processes.

Support audits and inspections by maintaining clear, accurate, and audit-ready documentation.

Contribute to continuous improvement initiatives related to sterilization performance, cost-efficiency, and regulatory compliance.

Stay up to date with evolving global sterilization standards, including ISO 10993-7 for residuals testing.

Requirements Bachelor’s degree in Engineering, Microbiology, Life Sciences, or a related field.

5–8 years of total experience in validation, protocol writing, execution, and lifecycle documentation.

Minimum of 1–2 years specifically focused on EtO sterilization in a GMP-regulated environment.

Strong understanding of EtO sterilization science and regulatory frameworks (e.g., FDA, ISO 11135, ISO 14937).

Excellent problem-solving and troubleshooting skills in sterilization validation contexts.

Strong organizational and documentation skills with attention to detail and data integrity.

Willingness to travel to client sites as project needs arise.

Benefits Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy. Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents

Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.

401(k) and 401(k) matching

PTO, Sick Time, and Paid Holidays

Education Assistance

Pet Insurance

Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more).

Financial Perks and Discounts

Equal Opportunity Employment Statement: PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs,  including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

#LI-JD1